510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193497Substantially Equivalent

Fixone Biocomposite Interference Screw

Aju Medical Co., Ltd., Seongnam-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193497 is the FDA 510(k) clearance record for Fixone Biocomposite Interference Screw, a class II device, cleared for Aju Pharm Co., Ltd. on under FDA product code HWC (Screw, Fixation, Bone). FDA records list 10 510(k) clearances for Aju Medical Co., Ltd., from to . As of , FDA records show 8 recalls naming K193497.

Clearance record

Decision date
Received
(385 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Aju Pharm Co., Ltd. A-207, 697, Pangyo-Ro, Seongnam-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HWC

Trailing 12 months
21 clearances under product code HWC in the twelve months to October 2026, May 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code HWC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20262
April 20263
May 20264
June 20262
July 20261
August 20263
September 20264
October 20260